Happy
New Year, everyone! I hope you are all healthy and ready to take
another one on with all that it might bring us.
I
was happening to read this article the other day and it made me
chuckle that they actually look at cholesterol numbers this
way:
https://www.wsj.com/articles/high-cholesterol-it-must-be-january-11547814600.
The article is worth a read, but to summarize: apparently, our
cholesterol goes up over the holidays, and if we were to measure it
in January we would see that, because we fall off the wagon and we
eat all those rich, unhealthy foods over the holidays, and too much
of them.
I
chuckled to myself because diet is not really a factor for my
cholesterol numbers, this time of the year or ever, because:
- I have HoFH which is really not influenced much by diet, if at all
and - I don't change what I eat when we're around holidays. I can't because I am allergic to all those rich foods that could raise my cholesterol (like meats, dairy, eggs and the likes).
But
what do you know, I went in for a cholesterol check and these were my
numbers:
<insert
funny, deflating sound of disappointment here>
So,
diet is a moot point for me, so what could be the culprit for these
crazy numbers?! As you can tell, the jump is huge.
Truth
be told, the numbers I got last time surprised me as being way too
low. Since I started Praluent, my Total Cholesterol hangs around
190's and my LDL around 140-150s. So, I saw the results in September
as a fluke, too. But these new numbers are scary, considering the
full cocktail I am on. For a list of all my medications, see
http://livingwithfh.blogspot.com/2016/07/my-current-drug-regimen-and-diet.html.
My
doctor and his nurse have been trying to figure out what happened.
The following has been their inquiry process to try to get to the
bottom of this change:
- Did I stop the Praluent or any of my other medications? No, I did not change even one thing about my medication. No change in the time, dose, pattern of injecting the Praluent.
- Did I not use my thigh to inject the Praluent? Did I use my stomach? No, I did not. I have always used my thigh, alternating between the thighs from one injection the to next.
- Did I inject every 1st and 15th of the month “to be exact in the break between the shots”? I corrected them: I always inject the Praluent on a Wednesday every two weeks. This (and not the 1st and the 15th of every month) will always ensure an equal amount of days between the shots. The nurse agreed with me. She, apparently “never thought about it, but I was right.”
- Did I not refrigerate my Praluent? Nope. The first thing I do when it comes off the UPS/ FedEx truck is to put it in the fridge. ( you will find literature out there that says that even if you do not refrigerate it, it should be OK to use for up to 30 days, but I don't believe that, really).
Besides
the detective work that the doctor and the nurse did with me, I
called a friend who is a medical researcher and has been involved in
researching Praluent particularly since it was in clinical trials. I
asked them if there is any evidence of developing resistance to the
medication after a while. This happened with the statins for me, and
I had to add additional drugs to support the statin. The answer was:
nothing like it has ever been found and they have had people that
have been on Praluent now for 6 years (double of the amount of time I
have been on it) and they never noticed resistance.
Well,
all this work was interesting, but I still had no answers. I did
notice one difference in the shot, though: the last two shots that I
took right before the cholesterol test were excruciatingly painful. I
always whine that they hurt, but those two times I literally screamed
and started crying instantly. They burned and hurt like
crazy.
So, I told the nurse that. She said, “well, that must be it. You
got a bad batch of Praluent.”
Now,
how would I know for sure? She asked if I had the LOT number
from those injections that hurt (the last ones) and of course I don't
anymore, but I am keeping closer records now. She gave me a number
for the My Praluent line to speak with the manufacturer about what
happened: the fact that the injection hurt more than usual (they
consider this to be a “reaction” that needs to be reported to
Regeneron/ Sanofi), and the fact that my numbers went up with no
other explanation.
I
called the number (which actually redirected me to Sanofi who is
marketing the drug, after selecting the extension for “reporting an
adverse reaction”) and they, too, were not able to help very much.
They
asked me the same questions that my doctor has already asked. In
addition, they also suggested that maybe “I need to increase the
dose, as the current dose stopped working”. Umm... that is not
possible because I am already on the 150mg pen which is the highest
dose approved for Praluent. So, not a go there.
They
only are guessing that somehow, one of the entities handling
the drug (could be the warehouse, or anyone in the transportation of
the drug from any leg of the trip until the drug got to me)
mis-stored the box with the pens in it. The drug has to be
refrigerated but not frozen. With the low temperatures we have been
seeing for the past several months, who knows? Maybe it froze on the
truck to one place or to my house?! Without a LOT number, they cannot
do much and right now they do not have any recalls recorded. So, they
are not aware of any certain batches that were bad, so the
mishandling must be the problem here.
They
said I will get a lot of paperwork in the mail to fill out and I
should send it back to them and this is what they will use if they
need to build a case for a recall, in case they get similar reports
from other patients.
They
also said if they do have a recall they notify all the doctors that
are ordering the drugs (as you know, doctors work very closely with
the distributors of Praluent and Repatha, so they have close records
for those doctors, I would imagine) and the doctor should notify me
immediately. I already know my doctor is extremely efficient in
letting me know about recalls, as another medical device I order (and
of which my doctor is aware) had a recall a few months back and the
doctor emailed me on a Sunday, the day the FDA announced the recall.
So,
unfortunately, we don't know what happened, but we have some guesses.
Now, the plan is to continue with the Praluent, as it arrives from
the specialty pharmacy for the next month (so, two or three more
shots) and then repeat the test in the beginning of March. Hopefully,
the numbers will go back down to “my” normal.
Another
interesting thing did happen, however. After talking with the My
Praluent folks (who are not the same as my specialty pharmacy), I had
to order a new refill for the Praluent. I called the pharmacy and
ordered it, and nothing was changed on that end – the refill went
smoothly and routinely. I ordered it to be delivered with no
signature required, which is what I always select. The day when the
order shipped I got a call for the very first time in three years
(since I have been filling this drug) from a bot. They wanted to
remind me that I had placed an order for Praluent and that I did not
require a signature. And they wanted to ensure that I open the
package and I store it properly just the minute it arrives at my
door. Now, this was an interesting coincidence that I received this
very specific indication after doubting the storage and packaging of
this drug like never before, wasn't it?! I am trying to figure out
what prompted the call this time: is it more than one person
complaining that all of a sudden the drugs stopped working? Or was it
the brutal temperatures we're dealing with nowadays, the polar vortex
and the below human temps we have seen everywhere in the country?!
Like I said: I called My Praluent to tell them about the mishap, and
not my specialty pharmacy – so how could the two actually be
concerned about the handling of the drug right at this very moment
when I was doubting exactly that.
I
guess I will never know. As you can tell, I have tons of questions
and only a guess, at best, for an answer. I will continue with what
drugs I have, and we'll see what numbers I'll get in March. Hoping
for some good news …
Much
health and a warm rest of the winter to all!
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